FDA 510(k) clearances — page 65
clearances on record, most recent first.
Clearances — page 65
6,401–6,500 of 175,620- K241137 — Clear Moves Aligner
- K241140 — ViroZap Indoor Air Purifier, In Duct Model 1008
- K241145 — TLAB® Transvenous Liver Biopsy System (TF-18C)
- K241238 — LOOP LED Curing Light System (CLK01)
- K241690 — Logical Liner; World Liner; World Knee Patella
- K241945 — KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)
- K242046 — EXULT Knee Replacement System
- K242055 — Freefix Forearm Plating System
- K233541 — ARCHITECT Active-B12 (Holotranscobalamin)
- K233555 — AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask
- K233808 — LW Narrow Implant System
- K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
- K240898 — SteriTite rigid reusable sterilization container with MediTray Products
- K240967 — ValvuloPro Valvuloplasty Balloon Catheter
- K241225 — Silverlon® Wound Contact, Burn Contact Dressing
- K241917 — EARP Nerve Cuff Electrode
- K241934 — NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
- K240280 — Nano-Check RSV Test
- K240446 — Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +
- K240531 — SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment
- K241539 — Activmotion S
- K241963 — WERAY
- K233723 — Medical surgical mask
- K234125 — AtriClip FLEX-Mini LAA Exclusion System (ACHM)
- K240326 — Solar Lumbar Interbody Fusion System
- K240359 — PowerGlide Pro Midline Catheter
- K241209 — EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)
- K241464 — ARx® SAI Implant System
- K241906 — BioBrace® Reinforced Implant
- K241912 — BIOCHARGE
- K242050 — Montage Settable Bone Putty
- K220328 — EasyStat 300
- K231776 — Cell-Free DNA BCT
- K233287 — Vent Vial Adapter
- K233501 — LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)
- K233530 — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)
- K233725 — Spine Navigation System
- K233994 — VOLT Proximal Humerus 3.5 Plating System
- K234131 — Resolv Endoscopic Hemostat System
- K240169 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
- K240246 — Accusafe Transseptal Guidewire (GTR31180, GTR31230)
- K240401 — ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
- K240509 — STAR Apollo Mapping System
- K241028 — Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)
- K241078 — Tandem Mobi Insulin Pump with interoperable technology
- K241187 — Alien Aligners
- K241494 — Pantheon Pedicle Screw and Iliac Bolt Fixation System
- K241515 — NEXA NPWT System
- K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
- K241845 — Introcan Safety® 2 IV Catheter
- K241866 — InnovaMatrix®FD
- K241883 — DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)
- K241898 — Symbia SPECT and SPECT/CT Systems
- K233372 — KARL STORZ Fiber Telescopes for Urology
- K233563 — Navident
- K240886 — Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)
- K241063 — s-Clean ScanHealing Abutment
- K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH)
- K241171 — Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories
- K241203 — PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT)
- K241361 — Arthrex Synergy Vision Endoscopic Imaging System
- K241864 — Grappler Interference Screw System
- K241887 — GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)
- K230305 — THE Graft Collagen
- K231251 — FlexWing Anterior Cervical Plate System
- K233352 — Aptima HCV Quant Dx Assay
- K233865 — X-Smart Pro; X-Smart Pro+
- K240044 — CADDIE
- K240431 — ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface
- K240457 — C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
- K240714 — Insure® Universal; Insure® Universal Automix
- K240780 — InMode RF System
- K241130 — POINT Kinguide Agile Hybrid Navigation System (PSHF01-000)
- K241150 — MISTI Silicone Implant
- K241243 — Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)
- K241502 — P-SCOPE
- K241789 — Non-Sterile Ultrasound Transmission Gels
- K241863 — Erisma® Lp Spinal Fixation System; Erisma® LP MIS
- K240756 — AITRICS-VC
- K240906 — TE Air Diagnostic Ultrasound System
- K241114 — EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)
- K241296 — Gaudi Proximal Humerus Plate
- K231133 — neo315
- K234091 — Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
- K240339 — Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08)
- K240558 — NAVOYCDS
- K240704 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System
- K241116 — Onycho Laser V
- K241119 — Transcutaneous Electrical Nerve Stimulator (K6106)
- K241445 — K-Bond Universal
- K241482 — Kinos Total Ankle System
- K240347 — PTG-05
- K233067 — Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
- K233866 — Senhance Surgical System
- K233976 — VasoGuard (V10, V8, V6, V4, V2)
- K233979 — VACUETTE® QUICKSHIELD Complete (Plus)
- K240480 — IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)
- K240538 — Premium Teeth Resin
- K240835 — Suture Button Repair System
- K241809 — coactiv+ Antimicrobial Wound Gel
Data sourced from openFDA. This site is unofficial and independent of the FDA.